Duration of response: Time from objective response to disease progression [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Overall survival [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Safety: Incidence of adverse events [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Determination of biomarkers indicative for response (serum and tumour tissue analyses) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Patients With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment

Official Title ICMJE

A Multicenter, Single Arm, Open-Label PhIV Study to Investigate the Effect of First-Line Herceptin (Trastuzumab) in Combination With a Taxane in Patients With Metastatic Breast Cancer Who Relapsed After Receiving (Neo)Adjuvant Herceptin for HER2-Positive Early Breast Cancer

Brief Summary

This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastutumab) in combination with a taxane as first line therapy in patients with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment. Patients will receive Herceptin (loading dose of 4 mg/kg intravenously [iv], 2 mg/kg iv weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease progression or unacceptable toxicity occurs.